National Cancer Institute (NCI)
This phase I trial studies the safety and side effects of glofitamab plus a chemoimmunotherapy regimen called R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) in treating patients newly-diagnosed with HIV-associated large B-cell lymphoma. Glofitamab is a bispecific monoclonal antibody, which can bind to two different antigens that are expressed by cancer cells (CD3 and CD20) at the same time. This may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Giving glofitamab in combination with the R-CHOP regimen may be a safe treatment for patients with newly-diagnosed with HIV-associated large B-cell lymphoma.
PRIMARY OBJECTIVE: I. To establish the feasibility and safety of the regimen glofitamab plus rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone (Glofit-RCHOP) in people with newly diagnosed Human Immunodeficiency Virus (HIV)-associated large B-cell lymphoma (LBCL). SECONDARY OBJECTIVES: I. To evaluate the toxicity of Glofit-RCHOP when utilized in combination with antiretroviral therapy (ART) as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. II. To evaluate the overall response rate (ORR) and complete response r…
Inclusion Criteria: * Participant is able to understand and willing to sign a written informed consent document * Participants must have histologically (via at least a core or ideally, incisional or excisional biopsy) documented CD20 positive newly diagnosed HIV-associated LBCL as per World Health Organization (WHO) 5th edition, diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS); high grade B-cell lymphoma-NOS or DLBCL/high grade B-cell lymphoma with MYC and BCL2 rearrangement. Plasmablastic lymphoma and primary effusion lymphoma may be included only if CD20-positive * Stage…
Undergo tumor tissue biopsy
Undergo blood sample collection
Undergo bone marrow biopsy or aspiration
Undergo bone marrow biopsy or aspiration
Undergo PET/CT
Given IV
Given IV
Undergo ECHO
Given IV
Undergo PET/CT
Given PO
Ancillary studies
Given IV
Given IV